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Blockade of the binding between Neonatal Fc receptor (FcRn) and IgG-Fc reduces circulating IgG, and thus emerges as a potential therapy for IgG-mediated autoimmune conditions. This was a double blind, randomized, single ascending dose study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HBM9161 (a humanized FcR monoclonal antibody) in healthy Chinese volunteers. Subjects were randomized to receive a single SC dose of HBM9161 or placebo in a 31 ratio in three dosing cohorts (340 mg, 510 mg, or 680 mg respective

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43, 95% CI 0.29-0.57; 59 estimates; χ heterogeneity p0.001; I =92%). SMD was greatest in carotid atherosclerosis (SMD 0.58, 95% CI 0.30-0.86; 17 estimates), followed by coronary (SMD 0.43, 95% CI 0.24-0.62; 33 estimates), lower extremity (SMD 0.26, 95% CI -0.02-0.54; 7 estimates), and renal atherosclerosis (SMD -0.07, 95% CI -2.77-2.64; 2 estimates) (χ heterogeneity p0.001; I ≥80% for all). Subgroup analysis revealed that sCD40L levels were increased in clinical, but not subclinical, atherosclerosis.